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Public trust in universities and research institutes is embedded in notions of intellectual integrity and independence. Crucial to this trust is the belief that these virtues are protected by an environment that values intellectual freedom, an unfettered exchange of information and ideas, and the pursuit of research for the public good. Of late, however, this trust is threatened by the increasing involvement of industry in research funding and a blurring of research ideals and corporate interests.^1,2

At the present time, this situation is more acute in the United States, but, as our governments, universities and research institutes increasingly pursue policies which blend research creativity and corporate capital,^3-5 there is no reason to believe that Australia will escape placing research integrity and public trust at risk.

Developments in the United States that have prompted a focus on the propriety of biomedical and clinical research include:

• A shift in the source of research funding from predominantly government and private foundations to industry. A substantial proportion of the US$55-$60 billion of industry research and development capital is now directed to basic biomedical research and clinical trials.⁶ Indeed, in 1999, the top 10 pharmaceutical companies spent US$22.7 billion primarily on clinical research, compared with the US$17.8 billion provided mostly for basic research by the US National Institutes of Health.²

• A shift away from academic centres to non-academic research organisations for the performance of clinical trials. In the United States, contract research organisations now receive up to 60% of the research funding available from the pharmaceutical industry for clinical trials.⁷ This shift has seen untoward effects on the control of trial design, the access to and analysis of data, and the publication of results.⁸ There is growing evidence that researchers with industry ties are more likely to report results favourable to corporate sponsors,^9-12 to conduct research of lower quality,^13,14 and to either delay publication¹⁵ or not to publish at all.^16,17

• A shift in the free flow of information. Researchers receiving funding from industry are more likely to restrict communications with their colleagues.¹⁸

• A shift to an entrepreneurial ethos in universities and research institutes. The securing of the all-important patent plays an increasing role in research and often represents the first move of researchers and institutions towards entrepreneurship. In the United States, university-generated patents have increased from about 250 per year before 1980 to nearly 5000 in 1998.¹⁹

At the centre of the disquiet attending these developments are concerns about conflict of interest — a conflict which may affect ethical behaviour, the quality of research undertaken, or the dissemination of its outcomes. Most guidelines for conflict of interest pertain to individual researchers or faculty members, but conflicts of interest may also apply to institutions such as universities or research institutes.

Can these entities effectively oversee their investigators when both the institutions and the investigators share parallel aspirations in acquiring industry funding, equity or royalties? In Australia, extensive examination of and public debate on conflict of interest involving institutions is of low priority; indeed, some of our leaders in academia, research and bureaucracy have dismissed this issue as irrelevant to the business of research.^20,21 Not so in the United States, where exploring the extent of and solutions to conflict of interest is firmly on the national agenda.^22,23 Indeed, Moses and Martin have recently advanced some general principles that may guide the exploration of appropriate frameworks.⁶ These include:

• The veracity of results of basic research and clinical trials research should not be compromised. Research integrity is best protected by isolating research from economic pressures.

• Oversight of the industry-research relationship should be by a disinterested party. Independent individuals without a financial stake should examine the relationship from its inception and at appropriate junctures.

• Proprietary rights, control of intellectual property and the right to publish should be established at the onset, with minimal caveats on non-disclosure and confidentiality and provisions to ensure future flexibility of research directions.

• Financial and non-financial incentives should be designed to fulfil the needs of both the researchers and the institution.

Potential solutions advanced by Moses and Martin to accommodate the fusion of industry, academia and research include:

• The creation by universities of separate entities to isolate commercially sponsored research from other research, yet still allow movement of researchers back and forth within defined limitations.

• The creation of entities independent of universities or research institutes to hold and control equity, thus solving the problem of the holding of equity by individuals. Individual components of equity could be managed as a portfolio of investments, with individuals assigned units of equity.⁶

All the above considerations are propelled by concerns about conflict of interest. But, as Korn recently noted:

Conflicts of interest are ubiquitous and inevitable in academic life; indeed, in all professional life. The challenge for academic medicine is not to eradicate them, which is fanciful and would be inimical to public policy goals, but to recognize and manage them sensibly and effectively.²⁴

In 2000, the US Department of Health and Human Services sponsored a conference to explore new ways to deal with financial conflict of interest and to ensure the integrity of research and the protection of human subjects in research.²² Such a public discourse is long overdue in Australia. We are at the beginning of industry involvement in research and this involvement should be vigorously promoted and pursued. But, instead of some time in the future, inheriting the US concerns about the propriety of biomedical research and clinical trials, should we not now confront institutional conflict of interest by open inquiry and the formulation of national guidelines? This will require a more visible leadership by the national overarching bodies in academia, science and medical research. Failure to do so will only lead to the impression that research is yet another commercial commodity and invite the inevitable erosion of public trust. Without public trust medical research is doomed.

Martin B Van Der Weyden
Editor, Medical Journal of Australia

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19. The United States Association of University Technology Managers (AUTM). The AUTM Licensing Survey. FY 98. http://www.autm.net/ and http://www.autm. net/pubs/survey/1998/execsumm.html (accessed September 2001).
20. Quiddington PT. When science, knowledge, truth and sex collide. Science debate turns up the heat. Campus Review August 29-Sept 4 2001; 1.
21. Moynihan R. The devil's dollar: the commercial pressure on science and medicine. The Australian Financial Review, 2001; Sept 8-9: 22-23.
22. Agnew B. HHS Conference on conflict of interest in clinical research will raise a new question: should research universities worry about their own conflicts of interest? Washington Fax July 20 2000 <http:// www.washingtonfax.com/p1/ 2000/20000720.html> (accessed September 2001).
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24. Korn D. Conflicts of interest in biomedical research. JAMA 2000; 284: 2234-2237.

©MJA 2001
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